Amphastar (AMPH) Q3 2026 Earnings Call Transcript

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DATE

Thursday, Nov. 5, 2026

CALL PARTICIPANTS

• Senior Vice President of Corporate Communications – Dan Dischner
• CFO and Executive Vice President of Finance – Bill Peters
• Executive Vice President of Regulatory Affairs and Clinical Operations – Tony Marrs

TAKEAWAYS

• Total Net Revenues — $207.6 million, an 8% increase year over year driven by record sales of BAQSIMI and Primatene MIST.
• BAQSIMI Net Sales — $58.8 million, growing 10% year over year due to higher unit volumes that contributed $7.4 million in sales.
• BAQSIMI Pricing Impact — $2.2 million headwind, reflecting lower average selling prices from higher rebates and 340B pharmacy discounts.
• Primatene MIST Net Sales — $31.5 million, a 9% increase year over year supported by a price hike implemented in the second quarter and a 2.5% rise in in-store unit sales.
• Lidocaine Revenue — $16.6 million, representing 29% growth driven by increased demand resulting from a competitor shortage.
• Epinephrine Revenue — $15.3 million, a 19% year-over-year decrease due to slower product releases at the IMS facility during remediation efforts.
• Glucagon Revenue — $8.6 million, declining 37% year over year as a result of increased market competition and lower average selling prices.
• Ipratropium Bromide Revenue — $6.6 million, following the product’s commercial launch in April 2026.
• Teriparatide Revenue — $6.4 million, contributing to the growth of the other pharmaceutical products category following its December 2025 launch.
• ANP API Sales — $6.2 million, supporting a 9% overall increase in the other pharmaceutical products segment.
• Gross Margin — 48.0%, down from 51.4% in the prior-year period due to pricing pressure on high-margin products and increased manufacturing expenses at IMS.
• Adjusted Non-GAAP Diluted EPS — $1.14, an increase from $0.93 in the third quarter of 2025.
• IMS Remediation Costs — $2 million to $3 million in additional expenses for the quarter, with management expecting higher costs over the next two to three quarters.
• IMS Product Backlog — $12.5 million, reflecting competing demands on resources and increased controls at the facility.
• General and Administrative Expenses — $16.8 million, a 57% decrease primarily due to the absence of a one-time legal settlement recorded in the prior-year period.
• Research and Development Expenses — $20.1 million, a 10% decrease as the company lapped a one-time licensing payment from the previous year.
• Cash Flow from Operations — $43.3 million for the quarter, bringing the nine-month total to $142.5 million.
• Share Buyback Authorization — $50 million increase to the program authorized by the Board of Directors on Nov. 4, 2026.
• Q4 Revenue Guidance — High single-digit growth, incorporating a modest slowdown in IMS sales as the company prioritizes corrective actions.
• Insulin Aspart Timeline — Commercial launch targeted for 2027, subject to FDA approval of the biosimilar and interchangeable program.
• Product Filing Delays — AMP-005 and AMP-017 filings shifted from the first half of 2027 to the second half of 2027 due to standard development processes.

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RISKS

• Dan Dischner stated, “These activities affected production schedules and the timing of certain product releases during the quarter, resulting in lower sales of certain IMS manufacturing products and higher manufacturing expenses,” in reference to ongoing remediation at the IMS facility.
• Tony Marrs indicated that the company does not anticipate BAQSIMI net pricing will return to historical levels because the 3% price increase taken this year “does not fully offset” the impact of 340B duplicate discounting.
• Bill Peters noted that the company has “a larger back order” of $12.5 million from the IMS facility due to “competing demands on our resources” and the implementation of new quality controls.

SUMMARY

Amphastar Pharmaceuticals, Inc. (AMPH +2.28%) reported record quarterly revenue for the third quarter of 2026, driven by the commercial performance of its core diabetes and respiratory franchises. Management stated that growth was led by volume gains in BAQSIMI and price-driven increases for Primatene MIST, which offset pricing headwinds and operational constraints. The company is currently engaged in a comprehensive remediation program at its IMS manufacturing facility following an FDA warning letter, an initiative that has increased manufacturing expenses and slowed certain product releases. Despite these operational challenges, the company expanded its share buyback program and remains focused on its long-term pipeline, including biosimilar insulin and new proprietary formulations.

• Management is implementing measures to address duplicate 340B discounts for BAQSIMI, with CFO Peters stating, “the impact was significantly smaller than in the previous two quarters.”
• The company is developing a new Primatene MIST formulation, AMP-104, with a goal to file by the end of 2028 to comply with shifting environmental regulations regarding propellants.
• Tony Marrs noted that for AMP-104, the EPA “is on a drawdown for HFA, and so this is something the FDA has taken to eventually get rid of that as a propellant.”
• Management expect the insulin aspart biosimilar to benefit from underutilized capacity at the ANP facility for API and unused finished product capacity in Rancho Cucamonga.
• The company reported continued market share growth for ipratropium bromide, noting it remains the only generic in that market despite a slight sequential decline in sales due to initial inventory loading in the second quarter.
• Management indicated that while the AMP-018 GLP-1 generic remains on track for 2027, they expect it to be a “limited opportunity” due to the competitive market environment.

INDUSTRY GLOSSARY

• 340B: A U.S. federal program that requires drug manufacturers to provide outpatient drugs to eligible healthcare organizations and covered entities at significantly reduced prices.
• ANDA: Abbreviated New Drug Application, the process by which a generic drug receives FDA approval.
• API: Active Pharmaceutical Ingredient, the component of a drug that produces the intended effects.
• BAQSIMI: A dry powder form of glucagon administered intranasally to treat severe hypoglycemia.
• Biosimilar: A biological product that is highly similar to and has no clinically meaningful differences from an existing FDA-approved reference product.
• HFA: Hydrofluoroalkane, a propellant used in inhalers that is being phased down due to its global warming potential.
• Interchangeable: An FDA designation for a biosimilar that may be substituted for the reference product without the intervention of the prescribing healthcare provider.
• Primatene MIST: The only FDA-approved over-the-counter epinephrine inhaler for the temporary

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